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2022 | November / December 2022

Applications of polymeric resins in medical devices for life saving treatments

by cyb2025
A. Basso
adsorption
chromatography
Dialysis
Haemodialysis
Immunoadsorption
medical device
Purification
REGULATORY
resin

ALESSANDRA BASSO
Senior Business Development Manager, Purolite, An Ecolab Company, United Kingdom

ABSTRACT

Polymeric chromatographic resin beads are extensively used in life-saving and life-supporting medical devices. Applications include liver and kidney dialysis, for detoxification relating to hepatitis, alcohol/drug misuse, cirrhosis, fatty liver or cancers or for treating kidney chronic diseases. Other application where polymeric resins find application as medical devices is enteral nutrition for patients suffering from Cystic fibrosis, or for treatment of patients before organ transplantation, to ensure higher rates of survival, or as a treatment for several autoimmune disorders by therapeutic removal of antibodies and molecules from plasma, used. Significant potential for hazards is inherent when using a device for medical purposes and thus medical devices must be proven safe and effective before regulating bodies permit the device to be marketed in their country. This paper will explore applications of chromatographic separation resins in medical devices, differentiations of classifications of medical devices, and typical regulatory compliance requirements for polymeric beads when incorporated into medical devices or diagnostics.

Any device intended to be used for medical purposes is defined as a medical device. They enable healthcare providers to diagnose and treat patients to overcome sickness or disease, ultimately improving their quality of life.

ABOUT THE AUTHOR

In 2012, Alessandra Basso joined Purolite to set-up the Life Sciences division; since then more than 600 new products have been launched for the biocatalysis, solid phase peptide synthesis and chromatography. In close connection with R&D and the global sales network of Purolite, Dr. Basso supports customers worldwide in developing applications, and expanding the scope of the business to the food, pharmaceutical and chemical industries. Dr. Basso is author of more than 50 scientific papers in international journals.

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